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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 201370

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HEPARIN SODIUM (HEPARIN SODIUM)
1,000 UNITS/ML
Marketing Status: Prescription
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N201370
Product Number: 001
Approval Date: Jul 21, 2011
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information
HEPARIN SODIUM (HEPARIN SODIUM)
5,000 UNITS/ML
Marketing Status: Prescription
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N201370
Product Number: 002
Approval Date: Jul 21, 2011
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information
HEPARIN SODIUM PRESERVATIVE FREE (HEPARIN SODIUM)
1,000 UNITS/ML
Marketing Status: Prescription
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N201370
Product Number: 004
Approval Date: Jul 21, 2011
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information
HEPARIN SODIUM (HEPARIN SODIUM)
10,000 UNITS/ML
Marketing Status: Discontinued
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N201370
Product Number: 003
Approval Date: Jul 21, 2011
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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